ATTUNE 2545-00-169Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIAL DRILL STOP SIZE 9-10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295422549), received between Jun 6, 2024 and Feb 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT 2545-00-169 9-10 TIBIAL DRILL STOP BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312662 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN MACRO TIBIAL PREP DRILL GUIDE. SIZE 9-10. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047222 ↗MalfunctionJun 6, 2024Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT DRILL STOP DOES NOT LOCK INTO REAMER. IT IS CRACKED AT ONE END. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19475308 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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